Medical Supplier Auditor – Save the Children – DRC
- Kinshasa, Kinshasa, République démocratique du Congo
- Catégorie de l'Offre: Management de programme
- Date de l'offre:13 Avr 2017
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Description du Poste
Save the Children is the world’s leading independent organisation for children. We work in 120 countries. We save children’s lives; we fight for their rights; we help them fulfil their potential.
We work together, with our partners, to inspire breakthroughs in the way the world treats children and to achieve immediate and lasting change in their lives.
We have over two million supporters worldwide and raised 1.9 billion dollars last year to reach more children than ever before, through programmes in health, nutrition, education, protection and child rights, also in times of humanitarian crises.
Following a major transition, our international programmes are now delivered through a merged operation with c15,000 staff, managed through seven regional hubs and reporting to a relatively small, central office. We’re changing to become more efficient, more aligned, a better partner, a stronger advocate, a magnet for world-class people and relevant for the 21st century.
Contract length: 2 months
SCI seeks technical support to conduct MQAS audits of five (5) pre-selected healthcare commodity suppliers in DRC. The consultant will work as a lead-auditor, accompanied by a representative of GPT. The consultant will follow SCI assessment guidance (Assessment methodology based on WHO MQAS and WHO GDP standard).
The consultant is expected to carry out the following key tasks:
1 Review background quality documentation from each supplier in advance of the audit and develop an audit plan and focus areas for an audit. This must be communicated to the GPT and agreed in advance of the audit. 2 Conduct and lead a quality on-site assessment of five (5) healthcare commodity suppliers located in DRC: The auditor is expected to use the SCI audit tool, following the priniciples of WHO MQAS and WHO GDP. 3 To prepare and submit, within 30 calendar days of the inspection, a final WHO MQAS and GDP inspection report of the supplier:
• This report must outline all activities conducted and all observations, including adherence to the WHO MQAS and WHO GDP standard and good practice. It must also include deviations and non-conformities to the WHO MQAS/GDP standard. The report must clearly define and categorise the observed deficiencies and recommendations on corrective/preventative action required for each, to easily facilitate corrective action and preventive actions (CAPA) by the wholesaler.
• To ensure that any non-conformities/ deviations from the WHO MQAS/ GDP standard have been addressed with CAPA by each manufacturer before issuing the final report. This must be done by checking for evidence of implementation for each within 15 calendar days of the report being sent to the wholesaler.
• To provide SCI with procurement recommendations in terms of WHO MQAS/WHO GDP compliance on purchasing based on the inspections and the follow up.
Qualifications and experience
• Advanced degree in pharmacy or Advanced degree in chemistry
• Suitable qualifications, knowledge and experience of pharmaceutical Quality Assurance and Quality Management Systems
• Experience (> 10 years) in management of health and pharmaceutical supply with relevant recent (less than 2 years) expertise on auditing/pre-qualification of manufacturer and/or wholesale.
• Inspector with GMP/GDP experience (past or present) in Stringent National Medicines Authorities or in international organisation such as WHO prequalification program; or practical experience as auditor, according to international standards (EU/US FDA/WHO) and preferably in developing countries;
• Familiarity with WHO MQAS and WHO GDP and best practice guidance on supply chain (Good manufacturing practise, Good Storage practices and Good distribution practises).
• Fluent speaking/written English and French is required (note that the audit will be conducted in French and the report must be provided in English)
• Experience in working in developed countries
We need to keep children safe so our selection process reflects our commitment to the protection of children from abuse.
To see a full a job description, please visit our website at www.savethechildren.net/jobs
Please apply in English or in French using your CV and covering letter as a single document, including your salary expectations for this role.
Please note that only shortlisted candidates will be contacted.
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